País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
AZITHROMYCIN MONOHYDRATE (UNII: JTE4MNN1MD) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)
RPK Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Azithromycin for oral suspension USP is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2)] [see Use in Specific Populations (8.4) and Clinical Studies (14.2)] Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or
Product: 53002-2231 NDC: 53002-2231-1 15 mL in a BOTTLE, PLASTIC NDC: 53002-2231-2 30 mL in a BOTTLE, PLASTIC
Abbreviated New Drug Application
AZITHROMYCIN- AZITHROMYCIN POWDER, FOR SUSPENSION RPK PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AZITHROMYCIN FOR ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AZITHROMYCIN FOR ORAL SUSPENSION. INITIAL U.S. APPROVAL: 1991 RECENT MAJOR CHANGES Warnings and Precautions, Cardiovascular Death (5.5) 11/2021 INDICATIONS AND USAGE Azithromycin for oral suspension USP is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: • • • • • • • • Limitation of Use: Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors. (1.3) To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.4) DOSAGE AND ADMINISTRATION • • INFECTION RECOMMENDED DOSE/DURATION OF THERAPY Acute otitis media (6 months of age and older) 30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5. Acute bacterial sinusitis (6 months of age and older) 10 mg/kg once daily for 3 days. Acute bacterial exacerbations of chronic bronchitis in adults (1.1) Acute bacterial sinusitis in adults (1.1) Uncomplicated skin and skin structure infections in adults (1.1) Urethritis and cervicitis in adults (1.1) Genital ulcer disease in men (1.1) Acute otitis media in pediatric patients (6 months of age and older) (1.2) Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2) Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) (1.1, 1.2) ADULT PATIENTS (2.1) INFECTION RECOMMENDED DOSE/DURATION OF THERAPY Com Leer el documento completo